13 Aug
|
Shalina Healthcare
|
Pune
13 Aug
Shalina Healthcare
Pune
Job Purpose
To lead and manage Tablet manufacturing operations at the Jejuri facility, ensuring achievement of production targets, GMP/cGMP compliance, product quality, productivity, manpower efficiency, cost optimization, and timely execution of production plans. The role will also coordinate material movement and production-related activities between the Jejuri Warehouse and External Warehouse.
Role & responsibilities
Production Operations
- Overall responsibility for Tablet production operations at the Jejuri site.
- Plan, monitor, and achieve daily, monthly, and annual production targets.
- Ensure availability of RM, PM, manpower, equipment, and other resources for uninterrupted production.
- Monitor production constraints and coordinate with cross-functional teams for timely resolution.
- Drive capacity utilization, productivity improvement, process optimization, and cycle-time reduction.
GMP & Quality Compliance
- Ensure strict implementation of GMP/cGMP requirements across all production activities and shifts.
- Ensure adherence to SOPs, BMRs, BPRs, and Good Documentation Practices.
- Ensure proper employee gowning, hygiene, and GMP practices across production areas.
- Work closely with IPQA and Site Quality teams to address daily quality observations, shortfalls, deviations, and compliance requirements.
- Identify production risks and implement appropriate mitigation measures.
Production Planning & Documentation
- Prepare production plans and ensure timely execution as per business requirements.
- Ensure preparation and availability of BMRs and required materials from Warehouse.
- Ensure daily dispensing and material movement from Jejuri Warehouse to External Warehouse as per approved production plan.
- Ensure timely completion,
review, and submission of BMR/BPR to QA after batch completion.
- Review DPRs and prepare monthly MIS reports and management presentations.
- Ensure timely and accurate SAP transactions related to Production.
Cost & Budget Management
- Prepare and monitor Production CAPEX and OPEX budgets in line with AOP.
- Identify and implement cost-saving initiatives across manpower, materials, processes, and resources.
- Develop resource plans for productivity and cost optimization projects.
- Drive initiatives to improve manufacturing cost efficiency.
Manpower & Team Management
- Ensure availability of manpower as per approved shift schedules and production requirements.
- Manage attendance, leave, shift schedules, and related employee authorizations.
- Conduct technical, GMP, and on-the-job training for production staff and workers.
- Monitor team performance, productivity, discipline, and competency development.
Continuous Improvement & Capacity Enhancement
- Analyze process cycle time and implement process optimization initiatives.
- Identify opportunities for capacity enhancement and support production projections.
- Support recent setup requirements, equipment additions, and process improvements.
- Drive initiatives to improve Production Quality Index and overall manufacturing performance.
Risk & Compliance Management
- Identify, assess,
and implement mitigation plans for production-related risks.
- Ensure timely closure of CAPAs, deviations, and quality-related actions.
- Support internal, customer, corporate, and regulatory audits and ensure audit readiness.
- Maintain effective coordination with QA, IPQA, QC, Warehouse, Engineering, Planning, and Supply Chain teams.
Preferred candidate profile
Qualifications
- B.Pharm / M.Pharm Mandatory
- Additional qualification in Operations / Management will be an advantage.
Experience
- 12-15 years of experience in pharmaceutical manufacturing.
- Strong experience in Tablet manufacturing in a reputed pharmaceutical organization.
- Proven experience in managing production teams and end-to-end tablet manufacturing operations.
- Strong exposure to GMP/cGMP, production planning, BMR/BPR, SAP, CAPEX/OPEX, and productivity improvement.
Key Competencies
- Tablet Manufacturing & Production Planning
- GMP/cGMP Compliance
- BMR/BPR & Documentation
- Manpower & Shift Management
- Capacity Planning & Productivity Improvement
- Cost Optimization
- CAPEX & OPEX Management
- SAP Production Transactions
- Risk Management
- Cross-Functional Coordination
- Team Leadership & People Development
Key Performance Indicators
- Production plan adherence and target achievement.
- Capacity utilization and manufacturing productivity.
- Process cycle-time improvement.
- GMP and quality compliance.
- Timely BMR/BPR completion and submission.
- Manpower productivity and shift availability.
- Production CAPEX/OPEX adherence.
- Reduction in production deviations and quality observations.
- Cost-saving and continuous improvement initiatives.
📌 Manager - Production (Tablet) | Shalina Laboratories Pvt Ltd (Pune)
🏢 Shalina Healthcare
📍 Pune